Investigator Responsibilities

When the UNC Charlotte Institutional Review Board (IRB) has reviewed and approved your IRB protocol, you will receive notification of approval. While the IRB oversees the conduct of your study from the prospective of the protection of human subjects, it is your responsibility to make certain that your research is conducted in accordance with the approved protocol application, federal regulations which govern research with human subjects, and associated UNC Charlotte policies (e.g., data security, financial reporting, responsible conduct of research, etc.). These requirements apply to all UNC Charlotte faculty, staff and students. Please be sure that you understand your responsibilities.

Investigator Responsibilities

Investigators (faculty, staff, and student researchers) are responsible for maintaining IRB compliance throughout the course of the research project. This includes submitting amendments before making changes to approved procedures or study personnel, reporting adverse events immediately, completing continuing reviews as required, participating in post-approval monitoring, maintaining records after study completion, and formally closing the protocol when the research is complete.

For detailed guidance and compliance requirements, consult the Post Approval Investigator Responsibilities. General information is provided below.

Amendment – Study Changes

The study protocol and materials once approved are the only procedures and/or materials that can be implemented and used. Any changes to the study, including but not limited to, activities that subjects will complete or using procedures that are different than outlined or described in the approved protocol, require a modification to the ​protocol. Once the modification amendment has been approved, you may proceed with implementing the changes to the protocol.

It is important to note that changes in a protocol might, in turn, require a change in the consent form(s) for your project as well.

Adverse Events

Unanticipated problems or serious adverse events involving risk to human subjects must be reported to the IRB immediately. A report detailing the problem(s) should be submitted to the Office of Research Protections and Integrity immediately. Please refer to Reporting Adverse Events.

Continuing Review

The IRB determines how frequently your study must be reviewed/renewed based on the level of risk to the participants. Most studies that are not Full Board protocols do not require continuing review. However, in some cases, the IRB determines at the initial review that continuing review will enhance protections to human subjects. In other cases, continuing review is required by policy and/or by the sponsor. The IRB approval letter will state any continuing review requirements.

If your study requires continuing review, the Office of Research Protections and Integrity sends Investigators and/or Faculty Advisors renewal reminders 60 and 30 days in advance of the expiration of protocol approval. Renewal notices for student researchers are sent to the Faculty Advisor listed on the approved protocol. Plan to submit for renewal at least two (2) weeks in advance of the renewal deadline to allow adequate time for IRB renewal review.

Addition or REMOVAL of Personnel or Investigators

Submit an amendment to add or remove personnel from the protocol.

If additional personnel will be involved with your project, they must meet the human subjects’ educational requirement(s) in effect at the time they are brought into the study. New personnel cannot assume their roles in the study until they have completed Human Subjects Research training. Research team members not affiliated with UNC Charlotte may need to complete an Individual Investigator Agreement Form.

Post Approval Monitoring

All protocols are included in post approval monitoring and may be selected for post approval review. The post approval review may be 1) an internal Office of Research Protections and Integrity (ORPI) file audit, 2) a self-evaluation/assessment conducted by the Investigator and overseen by ORPI, or 3) a full review and audit of the study. In addition, ORPI will conduct administrative check-ins periodically with Investigators to determine the current status of the study.

Closure

Investigators must formally close the study protocol when the research is complete. Do not allow the IRB approval to simply expire. Expiration of approval may be an indicator of non-compliance and result in post-approval monitoring and auditing. Further, closing the study allows for records retention requirements to begin.

Record Keeping

In accordance with UNC Charlotte’s Policy Statement #306, “Research Utilizing Human Subjects,” consent forms must be kept for a minimum of three (3) years following closure of the IRB protocol. Study data may be kept indefinitely as long as all identifiers and codes have been removed from the data, thus rendering the data non-identifiable (i.e., the researcher cannot ascertain the identity of the participant directly or using study ID/codes).

Questions?

If you have any questions about the status of your study or questions related to human subjects, please contact the Office of Research Protections and Integrity: uncc-irb@charlotte.edu or 704‑687‑1871.

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